Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07471568

Comparison of Three Treatment Strategies for Traumatic AO Type A1 Vertebral Fractures

This retrospective study evaluates three different treatment approaches used for traumatic AO Spine Type A1 (A1) vertebral fractures: orthopedic bracing, percutaneous vertebroplasty, and spinal arthrodesis. Traumatic A1 fractures are stable compression fractures that occur after high-energy events such as falls, traffic accidents, or heavy lifting. These injuries often affect working-age adults and can lead to significant pain, temporary disability, and delays in returning to work. The study analyzes real-world clinical data from patients treated at Hospital 9 de Octubre in Valencia, Spain, between 2007 and 2025. Outcomes assessed include pain levels, duration of sick leave, time to return to work, final functional status, and the presence of complications. By comparing the results of these three treatment strategies, the study aims to identify which approach offers the best clinical recovery and work-related outcomes for patients with traumatic AO Spine Type A1 fractures.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Consorcio Hospital General Universitario de Valencia

Valencia, 46015, Spain

About this study

Traumatic AO Spine Type A1 (A1) vertebral fractures are stable compression injuries typically caused by high-energy mechanisms such as falls from height, road-traffic accidents, or heavy lifting. These injuries frequently affect adults of working age and may lead to acute pain, temporary functional limitations, and prolonged periods of sick leave. In the clinical setting represented in this study, affected patients underwent one of three treatment strategies: orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis.

Orthopedic bracing is the most commonly used conservative approach for stable vertebral compression fractures. In contrast, percutaneous vertebroplasty is a minimally invasive technique that provides immediate internal stabilization via injection of polymethylmethacrylate (PMMA) cement, potentially reducing pain and accelerating functional recovery. Spinal arthrodesis, although more invasive, may be selected in specific traumatic scenarios depending on fracture morphology, associated injuries, or surgeon preference. Despite the frequent use of all three strategies, comparative evidence regarding clinical, functional, and work-related outcomes in traumatic AO Spine Type A1 fractures remains limited.

This retrospective cohort study examines real-world outcomes of patients with traumatic AO Spine Type A1 vertebral fractures treated at Hospital 9 de Octubre in Valencia, Spain. The study includes clinical data collected between 2007 and 2025, covering patients who were managed with one of the three treatment modalities. Data elements include demographic characteristics, mechanism of injury, fracture level, pre-treatment pain scores, treatment type, functional recovery, duration of sick leave, return-to-work (RTW) dates, and long-term clinical status. These variables are systematically documented in the institutional dataset supporting the project.

Imaging studies, including radiographs, computed tomography (CT), and magnetic resonance imaging (MRI), were routinely performed at the institution to evaluate vertebral morphology, rule out ligamentous injury, and assess neurological involvement. Advanced imaging also provided objective confirmation of fracture stability, enabling classification as AO Spine Type A1.

The primary aim of this study is to compare overall clinical recovery among patients treated with orthopedic bracing, vertebroplasty, or arthrodesis. Secondary outcomes include duration of work disability, pain evolution, and the presence of complications or adverse events. Long-term outcomes are available for many patients, with the latest follow-up recorded in February 2025.

By analyzing outcomes across these three management strategies, the study seeks to clarify which approach provides the most favorable clinical and occupational results for adults with traumatic AO Spine Type A1 vertebral fractures. The findings may inform clinical decision-making, help refine treatment algorithms, and support more individualized management strategies for this common traumatic condition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older with a traumatic AO Type A1 vertebral fracture confirmed by clinical records and imaging studies. Patients must have been treated with one of the following management strategies: orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis. Complete clinical records must be available for review, including the mechanism of injury, level of the fracture, treatment performed, and follow-up information.

Patients younger than 18 years; patients with non-traumatic or osteoporotic vertebral fractures; vertebral fractures not classified as AO Spine Type A1; cases with incomplete medical records; or patients whose fractures were treated for indications other than trauma. Patients with missing essential follow-up data will also be excluded.

Treatment and study plan

Primary outcomes

  1. Functional Recovery Status at Final Follow-Up

    Time frame: Up to 12 months after study inclusion or until the final planned follow-up visit.

    Degree of functional recovery after treatment of traumatic AO Spine Type A1 vertebral fractures, assessed using the final documented clinical status categories recorded in the medical chart. Functional categories include:

    full recovery minor residual spinal pain partial work disability no return to work permanent disability

    Higher categories indicate worse functional outcome (e.g., "full recovery" is the best outcome; "permanent disability" is the worst).

Secondary outcomes

  1. Pain Intensity Change (VAS)

    Time frame: Through study completion, up to 12 months after injury.

    Change in pain intensity measured using the Visual Analog Scale for pain (VAS).

    The VAS ranges from 0 to 10, where:

    0 = no pain 10 = worst imaginable pain

    Higher VAS scores indicate worse pain. The measure compares pre-treatment VAS values with last follow-up VAS values documented in the registry.

  2. Duration of Sick Leave (Days)

    Time frame: Up to 12 months after injury.

    Number of days of temporary work disability, calculated from the injury date to the officially documented date of return to work.

  3. Functional Recovery Status at Final Follow-Up

    Time frame: Up to 12 months after study inclusion.

    Degree of functional recovery after treatment of traumatic AO Type A1 vertebral fractures, assessed using the final documented clinical status ("Full recovery," "Minor residual spinal pain," "Partial work disability," "No return to work," or "Permanent disability") extracted from clinical records.

  4. Return-to-Work Rate

    Time frame: Through study completion, up to 12 months after injury.

    Proportion of patients who successfully return to work after treatment for traumatic AO Spine Type A1 vertebral fractures, based on documented work-resumption status in the clinical record.

  5. Incidence of Treatment-Related Complications

    Time frame: Through study completion, up to 12 months after injury.

    Incidence of treatment-related complications documented in the medical record, including persistent pain, secondary procedures, new neurological symptoms, or other adverse events occurring after treatment for traumatic AO Spine Type A1 vertebral fractures.

  6. Radiological Outcomes

    Time frame: Through study completion, up to 12 months after injury.

    Evaluation of vertebral morphology changes after treatment, including vertebral body height, wedge deformity, and overall structural appearance as documented in radiographic and computed tomography (CT) imaging

  7. Radiological Assessment of Fracture Stability

    Time frame: Through study completion, up to 12 months after injury.

    Evaluation of radiological signs of stability or instability of the vertebral fracture on radiography and CT, including progression of collapse, kyphotic angulation, or evidence of motion on flexion-extension imaging when available.

  8. Radiological Assessment of Associated Injuries

    Time frame: Through study completion, up to 12 months after injury.

    Detection of associated radiological findings-including edema, ligamentous changes, or other vertebral abnormalities-on magnetic resonance imaging (MRI), CT, or radiography per institutional protocol.

Other outcomes

  1. Level of Vertebral Fracture Involved

    Time frame: Baseline

    Distribution of affected vertebral levels (T4-S1)

  2. Mechanism of Injury Distribution

    Time frame: Baseline

    Classification of injury mechanism (falls from height, road accidents, heavy lifting injuries)

  3. Mortality

    Time frame: Through study completion, up to 12 months after injury.

    Mortality rate documented in the clinical record from the time of injury through the end of follow-up.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Comparative Outcomes of Orthopedic Bracing, Percutaneous Vertebroplasty, and Spinal Arthrodesis for Traumatic AO Type A1 Vertebral Fractures: A Retrospective Clinical Study

Acronym: TRAUMA-A1

Important dates

Study start
2007
Primary completion
2025
Study completion
2027
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.